Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004464
Status:
COMPLETED
Last Update Posted:
2019-01-18
First Post:
1999-10-18
Brief Title:
Study of High Dose Cyclophosphamide in Patients With Severe Aplastic Anemia and Paroxysmal Nocturnal Hemoglobinuria
Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Overview
Official Title:
High Dose Cyclophosphamide for the Treatment of Severe Aplastic Anemia and Paroxysmal Nocturnal Hemoglobinuria
Status:
COMPLETED
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
OBJECTIVES I Confirm the efficacy demonstrated in a pilot study using high dose cyclophosphamide in patients with severe aplastic anemia
II Determine whether the addition of filgrastim G-CSF to high dose cyclophosphamide shortens the time to recovery in these patients
III Determine whether this regimen is efficacious in treating paroxysmal nocturnal hemoglobinuria
II Determine whether the addition of filgrastim G-CSF to high dose cyclophosphamide shortens the time to recovery in these patients
III Determine whether this regimen is efficacious in treating paroxysmal nocturnal hemoglobinuria
Detailed Description:
PROTOCOL OUTLINE Patients receive high dose cyclophosphamide IV on days 1-4 Beginning on day 10 patients receive filgrastim G-CSF until the absolute neutrophil count is greater than 1000mm3 for 2 consecutive days
Patients are followed every 3 months for at least 2 years and annually thereafter
Patients are followed every 3 months for at least 2 years and annually thereafter
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 96-01-17-02 | OTHER | None | None |
| JHOC-96011702 | None | None | None |
| JHOC-9611 | OTHER | None | None |
| 19913895 | OTHER | other | None |